Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity

Breast Cancer Clinical Trial

— Cog-RV  

Official title:

Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06267014
• Other study ID #: 2023-A02163-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Centre Francois Baclesse
• Contact: Adeline MOREL, MD
• Phone: 33231455050
• Email: a.morel[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation. Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 23
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients >18 years of age
• Patient with breast cancer for whom adjuvant chemotherapy has been administered; maintenance treatments (e.g. Trastuzumab, hormone therapy) are eligible,
• Maximum 2 years after completion of adjuvant treatment,
• Patients who have cognitive complaints at inclusion (answer yes to the question:

'Since your cancer treatment, have you had any difficulties with memory, concentration, etc.?)

• Patients planning to return to work or who have returned to work in the past year,
• Signature of informed consent prior to any specific procedure relating to the study,
• Patient affiliated to a social security system.

Exclusion Criteria:

• Patients suffering from illnesses or conditions that impair their ability to understand, follow and/or comply with study procedures,
• Patients with personality disorders and/or psychiatric pathology,
• Patients deprived of their liberty or placed under the authority of a guardian,
• Pregnant women

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer-related Cognitive Difficulties

Intervention

Behavioral:
• Virtual Reality sessions
One session during 10-15 minutes per week for 6 weeks.

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients adhering to the Virtual Reality program	Adherence is defined as the completion of at least 5 of the 6 sessions planned.	At 6 weeks